HQ Team
April 13, 2023: Fusion Pharmaceuticals, a Canada-based radiopharmaceuticals company, announced FDA clearance for its investigational new drug applications to treat solid tumors.
FPI-2068 is a bispecific Targeted Alpha Therapy designed to deliver radiation to tumor cells precisely. According to a Nasdaq filing, it is jointly developing the drug with AstraZeneca.
Actinium, a radioactive material found in uranium ores, treats multiple tumors such as head and neck squamous cell carcinoma, non-small lung cancer, and colorectal and pancreatic cancer.
The Hamilton-headquartered company uses imaging to identify patients who show drug uptake in tumors, increasing the likelihood of response to therapy.
Fusion plans to provide additional guidance on timelines for the FPI-2068 program after the initial experience with patient screening to better predict the pattern of patient enrollment.
Fusion will be operationally responsible for the phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.
Therapy pipeline
Fusion Pharmaceuticals Chief Executive Officer John Valliant, PhD, said FPI 2068 would be the first of two validated alpha-targeted therapies to enter clinical development trials after its pact with AstraZeneca.
The joint agreement allows discovery, development, and the option to co-commercialize Fusion’s proprietary technology platform with antibodies from AstraZeneca’s oncology portfolio.
It also will explore potential combination strategies involving existing assets in their respective portfolios.
The companies will “advance this and other programs under our broad collaboration agreement,” he said.
The company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc., and BWXT Medical to support Fusion’s growing pipeline of targeted alpha therapies.
Fusion has also collaborated with Merck to evaluate FPI-1434 and Merck’s Keytruda (pembrolizumab) in patients with solid tumors.
